Effect of Inspiratory Muscle Training (IMT) on Breathing, Balance, and Blood Pressure Maintenance in Spinal Cord Injury (SCI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Sustained Maximal Inspiratory Pressure (SMIP)
Study Overview
Brief Summary
The purpose of this study is to help understand how training breathing muscles will impact balance, blood pressure, and quality of life of participants with spinal cord injury.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Upper/lower/both extremity weakness or paralysis resulting from SCI with ASIA Impairment Scale (AIS) grades A-C who use a wheelchair as primary means of mobility.
- •≥1 year post-injury
- •Willingness to participate in the study and provide consent.
Exclusion Criteria
- •Inability to understand the consent form or consent process
- •Reliance on a mechanical ventilator.
- •Use of Betablockers
- •Inability to travel to The Miami Project for weekly sessions during intervention month
- •Any complication that would limit transfer ability, or compromise supine or sitting tolerance, including but not limited to:
- •Fracture, dislocation, or malformations affecting supine or sitting tolerance.
- •Spinal instability.
- •Pressure ulcers or skin integrity issues on contact surfaces that would prohibit sitting or lying in supine.
- •Individuals who are able to stand independently or with a walker
- •Unresolved deep vein thrombosis (DVT).
- •Hospitalization due to autonomic dysreflexia in the last 3 months.
- •Pregnancy determined by urine testing in sexually active females.
Outcomes
Primary Outcomes
Sustained Maximal Inspiratory Pressure (SMIP)
Time Frame: Week 12
SMIP measured in pressure-time units (PTU) will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop.
Root Mean Squared of Successive Differences between Normal Heartbeats (rMSSD)
Time Frame: Week 12
rMSSD, measured in milliseconds, will be derived from signals obtained by a Polar monitor (with elastic chest strap sensor) and analyzed using Kubios Heart Rate Variability (HRV) Analysis Software.
Functional Seated Balance
Time Frame: Week 12
Functional Seated Balance will be measured using the Function in Sitting Test for SCI (FIST-SCI). FIST-SCI consist of 14 different standardized seated balance tasks and scored on a 5-point ordinal scale from 0-4. A higher score indicates increased independence.
Quality of Life (QoL)
Time Frame: Week 12
QoL will be measured using the Quality of Life Index, SCI version (QOLI-SCI). QOLI-SCI is a set of two 37-items questionnaire with total scores ranging from 74 to 444 with the higher score indicating increased quality of life.
Independence
Time Frame: Week 12
Independence will be measured using the Spinal Cord Independence Measured (SCIM). SCIM has a total score ranging from 0-100 with the higher score indicating increased independence.
Percent Compliance of Training Sessions
Time Frame: 4 weeks
Feasibility of the IMT protocol will be reported as the percentage of completed daily sessions out of the 28 total session days.
Percent Compliance of Training Minutes
Time Frame: 4 weeks
Feasibility of the IMT protocol will also be reported as the percentage of completed total time out of the 840 minutes total expected session minutes(30 minutes daily for 28 days).
Maximal Inspiratory Pressure (MIP)
Time Frame: Week 12
MIP measured in cm H2O will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop
Standard deviation of normal R-R intervals (SDNN)
Time Frame: Week 12
SDNN, measured in milliseconds, will be derived from signals obtained by a Polar monitor (with elastic chest strap sensor) and analyzed using Kubios Heart Rate Variability (HRV) Analysis Software.
Systolic Blood Pressure (SBP)
Time Frame: Week 12
Brachial systolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.
Secondary Outcomes
- Maximal Expiratory Pressure (MEP)(Week 12)
- Inspiratory Duration (ID)(Week 12)
- Forced Vital Capacity(Week 12)
- Forced Expiratory Volume in one Second (FEV1)(Week 12)
- Peak Expiratory Flow (PEF)(Week 12)
- Heart Rate Variability (HRV) Frequency(Week 12)
- Diastolic Blood Pressure (DBP)(Week 12)
Investigators
Lawrence Cahalin
Clinical Professor
University of Miami